Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
RecruitingPhase 4
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Eye with open-angle glaucoma or suspected of open-angle glaucoma * Pseudophakic in eye of interest with Shafer grading ≥3 * ≤ 3 daily applications of topical glaucoma medications for ≥6 months (of which one is a nightly preserved PGA) * Good adherence to medication regimen - screening questions to be asked of potential subject: * In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%) * When was the last administration? (Last dose must have been within last 24 hours) * Presence of punctate epithelial erosions in the cornea (NEI scale \> 3) Exclusion Criteria: * Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion) * Use of topical or systemic immunosuppressor or immunomodulator drug (e.g., steroids, cyclosporine, lifitegrast, or antihistamines) * Use of preservative-free hypotensive medications * Any clinical contraindications to receiving intracameral bimatoprost implantation * History of recurrent conjunctivitis (e.g., allergic or atopic conjunctivitis) * History of partial or full corneal transplant * History of ophthalmic surgery (intraocular or tarsus-involving oculoplastic procedures) within last 6 months * History of subconjunctival glaucoma surgery (i.e., trabeculectomy, aqueous shunt, Xen implant) within last 6 months
About the study
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
What is being tested
- Durysta, Bimatoprost Intracameral Implant 10 µg (drug)
Sponsor: University of Miami · Participants: 20 · Started: Feb 9, 2026
Contact the study team
- Javier Paredes, BA, MBA · Phone: 305-326-6387
- Monica Arango, BA · Phone: 305-326-6351
Official record on ClinicalTrials.gov — NCT07217678
Locations in the U.S.
| Florida | Bascom Palmer Eye Institute, Miami |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.